Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-06-07 @ 2:03 AM
Study NCT ID:
NCT02994927
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2016-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}], 'ancestors': [{'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620232', 'term': 'avacopan'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D001379', 'term': 'Azathioprine'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@chemocentryx.com', 'phone': '650.210.2900', 'title': 'Clinical trial disclosure', 'organization': 'ChemoCentryx, Inc.'}, 'certainAgreement': {'otherDetails': 'The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication. Sponsor may request in writing, and the PI shall agree to, (a) the deletion of any Confidential Information, (b) any reasonable changes requested by Sponsor, or (c) a delay of such proposed submission for an additional period, not to exceed 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'An AE was considered treatment-emergent if the start date/time of the event was on or after the date/time of first dose of study drug through 56 days following the last dose administered during the randomized treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. The safety population included all subjects who were randomized and had received at least one dose of study drug.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 161, 'seriousNumAtRisk': 164, 'deathsNumAffected': 4, 'seriousNumAffected': 74}, {'id': 'EG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. The safety population included all subjects who were randomized and had received at least one dose of study drug.', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 164, 'seriousNumAtRisk': 166, 'deathsNumAffected': 2, 'seriousNumAffected': 70}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 31, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 36, 'numAffected': 30}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'notes': 'Worsening of vasculitis is reported as the Preferred Term of "anti-neutrophil cytoplasmic antibody-positive vasculitis".', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 46, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 30, 'numAffected': 26}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 56, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 39, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 43, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 46, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 54, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 33, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 48, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 42, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 47, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 46, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 38, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 33, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Granulomatosis with polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Microscopic polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute myocardial infarction', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Somatic symptom disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Disease Remission at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '77.0'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '64.8', 'upperLimit': '78.9'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Common difference in remission rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '12.8', 'estimateComment': 'Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference', 'statisticalMethod': 'Summary score test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.'}, {'pValue': '= 0.2387', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Common difference in remission rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '12.8', 'estimateComment': 'Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference', 'statisticalMethod': 'Summary score test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Disease remission at Week 26 was defined as:\n\n* Achieving a BVAS of 0 as determined by the Adjudication Committee;\n* No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;\n* No BVAS \\>0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Sustained Disease Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': '62.6'}, {'value': '65.7', 'groupId': 'OG001', 'lowerLimit': '57.9', 'upperLimit': '72.8'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Common difference in remission rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '2.6', 'ciUpperLimit': '22.3', 'estimateComment': 'Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference', 'statisticalMethod': 'Summary score test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.'}, {'pValue': '= 0.0066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Common difference in remission rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '2.6', 'ciUpperLimit': '22.3', 'estimateComment': 'Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference', 'statisticalMethod': 'Summary score test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Sustained remission at Week 52 was defined as:\n\n* Disease remission at Week 26 as defined above;\n* Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;\n* No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Number of subjects with at least one TEAE', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}, {'title': 'Number of TEAEs', 'categories': [{'measurements': [{'value': '2139', 'groupId': 'OG000'}, {'value': '1779', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with SAEs', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Number of SAEs', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with TEAE leading to discontinuation', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'AEs=Adverse events\n\nSAEs=Serious adverse events\n\nTEAE=Treatment-emergent adverse event', 'unitOfMeasure': 'Number', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'GTI-CWS (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'GTI-CWS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '3.43', 'groupId': 'OG001'}]}]}, {'title': 'GTI-AIS (Week 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '3.45', 'groupId': 'OG001'}]}]}, {'title': 'GTI-AIS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.4', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '3.48', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 13 and 26', 'description': 'GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;\n\nGTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;\n\nThe Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).', 'unitOfMeasure': 'Glucocorticoid Toxicity Index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '75.9'}, {'value': '62.7', 'groupId': 'OG001', 'lowerLimit': '54.8', 'upperLimit': '70.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;\n\nThe BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'SF-36v2: Physical Component Score (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.344', 'spread': '0.7432', 'groupId': 'OG000'}, {'value': '4.445', 'spread': '0.7332', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Physical Component Score (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.626', 'spread': '0.7505', 'groupId': 'OG000'}, {'value': '4.980', 'spread': '0.7435', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Physical Functioning (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '1.787', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '1.773', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Physical Functioning (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.809', 'groupId': 'OG000'}, {'value': '9.55', 'spread': '1.790', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Role Physical (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.52', 'spread': '2.198', 'groupId': 'OG000'}, {'value': '16.78', 'spread': '2.173', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Role Physical (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.27', 'spread': '2.228', 'groupId': 'OG000'}, {'value': '17.12', 'spread': '2.198', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Bodily Pain (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.82', 'spread': '2.197', 'groupId': 'OG000'}, {'value': '14.75', 'spread': '2.164', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Bodily Pain (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.87', 'spread': '2.220', 'groupId': 'OG000'}, {'value': '16.12', 'spread': '2.185', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: General Health Perception (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.89', 'spread': '1.428', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '1.405', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: General Health Perception (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.442', 'groupId': 'OG000'}, {'value': '5.84', 'spread': '1.420', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Mental Component Score (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.271', 'spread': '0.8403', 'groupId': 'OG000'}, {'value': '4.849', 'spread': '0.8273', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Mental Component Score (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.694', 'spread': '0.8491', 'groupId': 'OG000'}, {'value': '6.394', 'spread': '0.8406', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Mental Health (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.84', 'spread': '1.331', 'groupId': 'OG000'}, {'value': '8.29', 'spread': '1.318', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Mental Health (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.66', 'spread': '1.347', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '1.337', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Role Emotional (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '2.183', 'groupId': 'OG000'}, {'value': '7.32', 'spread': '2.158', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Role Emotional (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.14', 'spread': '2.212', 'groupId': 'OG000'}, {'value': '9.38', 'spread': '2.181', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Social Functioning (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.09', 'spread': '2.037', 'groupId': 'OG000'}, {'value': '14.50', 'spread': '2.002', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Social Functioning (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.56', 'spread': '2.059', 'groupId': 'OG000'}, {'value': '18.06', 'spread': '2.030', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Vitality (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.42', 'spread': '1.751', 'groupId': 'OG000'}, {'value': '12.03', 'spread': '1.727', 'groupId': 'OG001'}]}]}, {'title': 'SF-36v2: Vitality (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.48', 'spread': '1.770', 'groupId': 'OG000'}, {'value': '14.36', 'spread': '1.750', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D-5L VAS Score (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D-5L VAS Score (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D-5L Index Score (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0010', 'spread': '0.01462', 'groupId': 'OG000'}, {'value': '0.0229', 'spread': '0.01438', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D-5L Index Score (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0038', 'spread': '0.01471', 'groupId': 'OG000'}, {'value': '0.0474', 'spread': '0.01451', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)\n\nEQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels\n\nThe SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).', 'unitOfMeasure': 'Change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '19.6'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '13.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The median time to relapse was not estimable because of small number of relapsed subjects.\n\nA relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:\n\n1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or\n2. having achieved BVAS=0 at any time during the treatment period\n\nANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Subjects in the analysis population for the specified treatment group.\n\nITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '28.2'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '15.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The median time to relapse was not estimable because of small number of relapsed subjects.\n\nA relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:\n\n1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or\n2. having achieved BVAS=0 at any time during the treatment period\n\nThe Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Subjects who achieved BVAS=0 during the 52 week treatment period.\n\nITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '4.9'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '7.8'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '6.1'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '9.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.\n\neGFR=estimated glomerular filtration rate\n\nBVAS=Birmingham Vasculitis Activity Score\n\nMDRD=Modification of Diet in Renal Disease', 'unitOfMeasure': 'Change in eGFR (mL/min/1.73 m^2)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS).\n\nITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-16', 'upperLimit': '19'}, {'value': '-40', 'groupId': 'OG001', 'lowerLimit': '-50', 'upperLimit': '-28'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-70', 'groupId': 'OG000', 'lowerLimit': '-75', 'upperLimit': '-65'}, {'value': '-63', 'groupId': 'OG001', 'lowerLimit': '-69', 'upperLimit': '-56'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-77', 'groupId': 'OG000', 'lowerLimit': '-81', 'upperLimit': '-72'}, {'value': '-74', 'groupId': 'OG001', 'lowerLimit': '-78', 'upperLimit': '-69'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4, 26 and 52', 'description': 'BVAS=Birmingham Vasculitis Activity Score\n\nUACR=Urinary albumin:creatinine ratio', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Subjects With Renal Disease (based on BVAS) and Albuminuria (UACR\\>=10 mg/g creatinine) at Baseline\n\nITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-64', 'groupId': 'OG000', 'lowerLimit': '-67', 'upperLimit': '-59'}, {'value': '-67', 'groupId': 'OG001', 'lowerLimit': '-70', 'upperLimit': '-63'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-71', 'groupId': 'OG000', 'lowerLimit': '-74', 'upperLimit': '-67'}, {'value': '-73', 'groupId': 'OG001', 'lowerLimit': '-76', 'upperLimit': '-70'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'BVAS=Birmingham Vasculitis Activity Score\n\nMCP-1=monocyte chemoattractant protein-1', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Subjects With Renal Disease at Baseline (based on BVAS).\n\nITT Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}, {'type': 'SECONDARY', 'title': 'Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.090', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.091', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Leukocytes (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.69', 'spread': '0.338', 'groupId': 'OG000'}, {'value': '-5.94', 'spread': '0.387', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.54', 'spread': '0.365', 'groupId': 'OG000'}, {'value': '-5.62', 'spread': '0.395', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '0.338', 'groupId': 'OG000'}, {'value': '-5.24', 'spread': '0.380', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.89', 'spread': '0.361', 'groupId': 'OG000'}, {'value': '-4.95', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.100', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': '10^3 cells/μL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Eosinophils (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.018', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.019', 'groupId': 'OG001'}]}]}, {'title': 'Basophils (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Basophils (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.024', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.026', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-73.9', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '-77.1', 'spread': '9.30', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-75.5', 'spread': '8.01', 'groupId': 'OG000'}, {'value': '-73.8', 'spread': '9.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Erythrocytes (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.226', 'spread': '0.0450', 'groupId': 'OG000'}, {'value': '0.252', 'spread': '0.0432', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.244', 'spread': '0.0410', 'groupId': 'OG000'}, {'value': '0.279', 'spread': '0.0432', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': '10^12 cells/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Hemoglobin (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.120', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.125', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Hematocrit (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': 'percentage of red blood cells', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Lactate Dehydrogenase (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '5.68', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '5.40', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '4.80', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.6', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '76.8', 'spread': '10.34', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.6', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '9.68', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.2', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Creatinine (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.105', 'spread': '0.0569', 'groupId': 'OG000'}, {'value': '-0.195', 'spread': '0.0508', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.200', 'spread': '0.0416', 'groupId': 'OG000'}, {'value': '-0.244', 'spread': '0.0627', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.4', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Protein (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '50', 'groupId': 'OG000'}, {'value': '220', 'spread': '47', 'groupId': 'OG001'}]}]}, {'title': 'Protein (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160', 'spread': '48', 'groupId': 'OG000'}, {'value': '250', 'spread': '41', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.7', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '3.47', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '3.41', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.0182', 'groupId': 'OG000'}, {'value': '0.078', 'spread': '0.0250', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.0185', 'groupId': 'OG000'}, {'value': '0.057', 'spread': '0.0201', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. 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The number of subjects with data at baseline and the specified visit is reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs (5/5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'BMI (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.132', 'groupId': 'OG001'}]}]}, {'title': 'BMI (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.179', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'BMI=Body Mass Index', 'unitOfMeasure': 'kilogram(s)/ square meter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug. 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avacopan/placebo to an AE', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Relationship of glucocorticoid use to an AE', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Relationship of cyclophosphamide IV use to an AE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Relationship of oral cyclophosphamide use to an AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Relationship of rituximab use to an AE', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Relationship of azathioprine use to an AE', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Relationship of mycophenolate use to an AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'AE=Adverse Event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'title': 'Any Treatment-Emergent Infection', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Any Serious Treatment-Emergent Infection', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Any Severe Treatment-Emergent Infection', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Any Treatment-Emergent Infection Leading to Study Withdrawal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Treatment-Emergent Life-threatening Infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Treatment-Emergent Infection Leading to Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE Associated with Hepatic Abnormalities', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE Associated with Low WBC Counts', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE Associated with hypersensitivity', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'WBC=White Blood Cell\n\nTEAE=Treatment-Emergent Adverse Event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'BVAS=Birmingham Vasculitis Activity Score;\n\nA relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:\n\n1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or\n2. having achieved BVAS=0 at any time during the treatment period\n\nThe BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intended-to-Treat (ITT) Population: The ITT Population included all subjects who were randomized in the study and who received at least one dose of blinded study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone'}, {'id': 'FG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 143 study centers randomized at least 1 subject. The target enrollment was 300 subjects.', 'preAssignmentDetails': 'Screening details:\n\nOf 386 subjects screened, 331 were enrolled in the study and randomized to treatment. Reasons for subjects failing screening included not meeting inclusion/exclusion criteria, withdrawal by subject, adverse event (AE) and other.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prednisone Group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone'}, {'id': 'BG001', 'title': 'Avacopan Group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Adolescents (12-17 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Adults (18-50 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Adults (51-64 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Adults (65-75 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': 'Adults (>75 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Ireland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Geographic Region', 'classes': [{'title': 'North America', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Europe and Rest of World excluding Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ANCA-associated vasculitis Status', 'classes': [{'title': 'Newly diagnosed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}, {'title': 'Relapsed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ANCA=anti-neutrophil cytoplasmic autoantibody', 'unitOfMeasure': 'Participants'}, {'title': 'ANCA Positivity', 'classes': [{'title': 'Proteinase 3 (PR3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Myeloperoxidase (MPO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ANCA=anti-neutrophil cytoplasmic autoantibody', 'unitOfMeasure': 'Participants'}, {'title': 'Standard of Care Treatment', 'classes': [{'title': 'Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': 'Intravenous (IV) Cyclophosphamide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': 'Oral Cyclophosphamide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of ANCA-associated vasculitis', 'classes': [{'title': 'Granulomatosis with polyangiitis (GPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}, {'title': 'Microscopic polyangiitis (MPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ANCA=anti-neutrophil cytoplasmic autoantibody', 'unitOfMeasure': 'Participants'}, {'title': 'BVAS Entry Criteria', 'classes': [{'title': 'One or more major item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': 'Three or more minor items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}, {'title': 'Two renal items of proteinuria and hematuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'BVAS=Birmingham Vasculitis Activity Score;\n\nThe BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).\n\n\\* Subjects can appear in more than one category', 'unitOfMeasure': 'Participants'}, {'title': 'BVAS Components', 'classes': [{'title': 'General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}, {'title': 'Cutaneous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Mucous Membranes/Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Ear Nose and Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'Chest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Cardiovascular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Abdominal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Renal + Other (RBC Casts and/or Glomerulonephritis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}, {'title': 'Nervous System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'BVAS=Birmingham Vasculitis Activity Score\n\n\\* Subjects can appear in more than one category', 'unitOfMeasure': 'Participants'}, {'title': 'Age at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '14.50', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '14.56', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '14.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at diagnosis of ANCA-associated Vasculitis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.4', 'spread': '15.19', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '15.60', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '15.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ANCA=anti-neutrophil cytoplasmic autoantibody', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of ANCA-Associated Vasculitis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20.13', 'spread': '40.473', 'groupId': 'BG000'}, {'value': '22.93', 'spread': '52.464', 'groupId': 'BG001'}, {'value': '21.54', 'spread': '46.840', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ANCA=anti-neutrophil cytoplasmic autoantibody', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77.71', 'spread': '19.335', 'groupId': 'BG000'}, {'value': '76.43', 'spread': '20.254', 'groupId': 'BG001'}, {'value': '77.07', 'spread': '19.783', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram(s)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.78', 'spread': '5.212', 'groupId': 'BG000'}, {'value': '26.72', 'spread': '5.997', 'groupId': 'BG001'}, {'value': '26.75', 'spread': '5.612', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI=Body Mass Index', 'unitOfMeasure': 'kilogram(s)/square meter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects did not have a baseline BMI provided (one in each treatment group)'}, {'title': 'BVAS Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '5.69', 'groupId': 'BG000'}, {'value': '16.3', 'spread': '5.87', 'groupId': 'BG001'}, {'value': '16.2', 'spread': '5.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'VDI Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.39', 'groupId': 'BG000'}, {'value': '0.7', 'spread': '1.54', 'groupId': 'BG001'}, {'value': '0.7', 'spread': '1.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two subjects did not have a baseline VDI Score (one in each treatment group)'}], 'populationDescription': 'In the Prednisone group, one subject was randomized but withdrawn for not meeting disease criteria prior to dosing.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-18', 'size': 1164754, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-19T06:56', 'hasProtocol': True}, {'date': '2019-10-28', 'size': 1983980, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-19T08:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study was double-blind, double-dummy, i.e., placebo capsules were identical in appearance to the avacopan capsules, and prednisone capsules also had matching placebo capsules. To maintain the blind, multiple measures were taken (i.e., randomization code was not accessible to study personnel who had contact with study centers or who were involved in data management and analysis for the duration of the study).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2016-12-11', 'resultsFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-12', 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Disease Remission at Week 26', 'timeFrame': 'Week 26', 'description': 'Disease remission at Week 26 was defined as:\n\n* Achieving a BVAS of 0 as determined by the Adjudication Committee;\n* No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;\n* No BVAS \\>0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).'}, {'measure': 'Percentage of Subjects Achieving Sustained Disease Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Sustained remission at Week 52 was defined as:\n\n* Disease remission at Week 26 as defined above;\n* Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;\n* No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.'}], 'secondaryOutcomes': [{'measure': 'Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'AEs=Adverse events\n\nSAEs=Serious adverse events\n\nTEAE=Treatment-emergent adverse event'}, {'measure': 'Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI', 'timeFrame': 'Baseline, Week 13 and 26', 'description': 'GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;\n\nGTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;\n\nThe Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).'}, {'measure': 'Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC', 'timeFrame': 'Week 4', 'description': 'AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;\n\nThe BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).'}, {'measure': 'Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)\n\nEQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels\n\nThe SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).'}, {'measure': 'Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study', 'timeFrame': 'Week 52', 'description': 'The median time to relapse was not estimable because of small number of relapsed subjects.\n\nA relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:\n\n1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or\n2. having achieved BVAS=0 at any time during the treatment period\n\nANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).'}, {'measure': 'Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period', 'timeFrame': 'Week 52', 'description': 'The median time to relapse was not estimable because of small number of relapsed subjects.\n\nA relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:\n\n1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or\n2. having achieved BVAS=0 at any time during the treatment period\n\nThe Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).'}, {'measure': 'In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.\n\neGFR=estimated glomerular filtration rate\n\nBVAS=Birmingham Vasculitis Activity Score\n\nMDRD=Modification of Diet in Renal Disease'}, {'measure': 'In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks', 'timeFrame': 'Baseline, Week 4, 26 and 52', 'description': 'BVAS=Birmingham Vasculitis Activity Score\n\nUACR=Urinary albumin:creatinine ratio'}, {'measure': 'In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'BVAS=Birmingham Vasculitis Activity Score\n\nMCP-1=monocyte chemoattractant protein-1'}, {'measure': 'Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline in Vital Signs (1/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline in Vital Signs (2/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline in Vital Signs (3/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline in Vital Signs (4/5)', 'timeFrame': 'Baseline, Week 26 and 52'}, {'measure': 'Change From Baseline in Vital Signs (5/5)', 'timeFrame': 'Baseline, Week 26 and 52', 'description': 'BMI=Body Mass Index'}, {'measure': 'Number of Subjects With Clinically Significant ECG Changes From Baseline', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'Clinical significance was assessed by the individual reading of the ECGs\n\nECG=Electrocardiogram'}, {'measure': 'Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'AE=Adverse Event'}, {'measure': 'Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'WBC=White Blood Cell\n\nTEAE=Treatment-Emergent Adverse Event'}, {'measure': 'Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study', 'timeFrame': 'From day 1 throughout the study period (day 421/week 60)', 'description': 'BVAS=Birmingham Vasculitis Activity Score;\n\nA relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:\n\n1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or\n2. having achieved BVAS=0 at any time during the treatment period\n\nThe BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ANCA-associated vasculitis', 'complement', 'vasculitis', 'C5aR', 'avacopan', 'CCX168', 'MPA', 'GPA'], 'conditions': ['ANCA-Associated Vasculitis']}, 'referencesModule': {'references': [{'pmid': '41052893', 'type': 'DERIVED', 'citation': 'Geetha D, Neumann T, Karras A, Cid MC, Merkel PA, Bray S, Bozeman AM, Jayne DRW; Members of the ADVOCATE Study Group. Efficacy and safety of avacopan for treatment of patients with ANCA-associated vasculitis receiving cyclophosphamide. RMD Open. 2025 Oct 5;11(4):e005743. doi: 10.1136/rmdopen-2025-005743.'}, {'pmid': '37979959', 'type': 'DERIVED', 'citation': 'Geetha D, Dua A, Yue H, Springer J, Salvarani C, Jayne D, Merkel P; ADVOCATE Study Group. Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial. Ann Rheum Dis. 2024 Jan 11;83(2):223-232. doi: 10.1136/ard-2023-224816.'}, {'pmid': '35167187', 'type': 'DERIVED', 'citation': 'Soulsby WD. Journal Club Review of "Avacopan for the Treatment of ANCA-Associated Vasculitis". ACR Open Rheumatol. 2022 Jul;4(7):558-561. doi: 10.1002/acr2.11412. Epub 2022 Feb 15.'}, {'pmid': '33596356', 'type': 'DERIVED', 'citation': 'Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386.'}, {'pmid': '32088663', 'type': 'DERIVED', 'citation': 'Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc. 2020 Apr 7;9(4):e16664. doi: 10.2196/16664.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.', 'detailedDescription': 'Complement 5a and its receptor C5aR (CD88) are involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.\n\nThis is a randomized, double-blind, active-controlled Phase 3 study to evaluate the safety and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or Cyclophosphamide/Azathioprine.\n\nStudy acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis\n* Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be enrolled\n* Use of adequate contraception\n* Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)\n* At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS)\n* Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\\^2 at screening\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* Alveolar hemorrhage requiring pulmonary ventilation support at screening\n* Any other known multi-system autoimmune disease\n* Required dialysis or plasma exchange within 12 weeks prior to screening\n* Have a kidney transplant\n* Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1\n* Received intravenous glucocorticoids, \\>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening\n* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening\n* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count \\> 0.01x10\\^9/L); received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening\n* For patients scheduled to receive cyclophosphamide treatment, urinary outflow obstruction, active infection (especially varicella zoster infection), or platelet count \\<50,000/μL before start of dosing\n* Participated previously in a CCX168 study"}, 'identificationModule': {'nctId': 'NCT02994927', 'acronym': 'ADVOCATE', 'briefTitle': 'A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine', 'orgStudyIdInfo': {'id': 'CL010_168'}, 'secondaryIdInfos': [{'id': 'ADVOCATE', 'type': 'OTHER', 'domain': 'ChemoCentryx'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisone group', 'description': 'Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.', 'interventionNames': ['Drug: Prednisone', 'Drug: Cyclophosphamide', 'Biological: Rituximab', 'Drug: Azathioprine']}, {'type': 'EXPERIMENTAL', 'label': 'Avacopan group', 'description': 'Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.', 'interventionNames': ['Drug: Avacopan', 'Drug: Cyclophosphamide', 'Biological: Rituximab', 'Drug: Azathioprine']}], 'interventions': [{'name': 'Avacopan', 'type': 'DRUG', 'otherNames': ['CCX168'], 'description': "Avacopan 30 mg twice daily orally for 52 weeks (364 days):\n\n\\- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.\n\nOral prednisone-matching placebo tapering regimen over 20 weeks (140 days):\n\n* Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \\<55 kg, starting on Day 1 with tapering according to a protocol-specified schedule.\n* Adolescents who weighed ≤37 kg started at a prednisone-matching placebo dose of 30 mg per day.", 'armGroupLabels': ['Avacopan group']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': "Avacopan-matching placebo twice daily orally for 52 weeks (364 days):\n\n\\- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.\n\nOral prednisone tapering regimen over 20 weeks (140 days):\n\n* Prednisone 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \\<55 kg, starting on Day 1 with tapering according to the protocol-specified schedule.\n* Adolescents who weighed ≤37 kg started at a prednisone dose of 30 mg per day.", 'armGroupLabels': ['Prednisone group']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Orally or intravenously administered', 'armGroupLabels': ['Avacopan group', 'Prednisone group']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'description': 'Intravenously administered', 'armGroupLabels': ['Avacopan group', 'Prednisone group']}, {'name': 'Azathioprine', 'type': 'DRUG', 'description': 'Orally administered', 'armGroupLabels': ['Avacopan group', 'Prednisone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 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relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}